News | Balloon Catheter | June 13, 2024

FDA Announces Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits

The Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits are being recalled for manufacturing issues that may prevent full balloon inflation and cause patient harm

The Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits are being recalled for manufacturing issues that may prevent full balloon inflation and cause patient harm

June 13, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and their subsidiary Arrow International, are recalling the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits after finding that a manufacturing error may cause the catheter’s balloon to become overtwisted. This issue may prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use.

The FDA has identified this as a Class I recall, the most serious type of recall. Please be aware, this recall is a correction, not a product removal. Use of these devices without correction, may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal.

Recalled Product

  • Product Name: Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit
  • Product Codes:
    • IAB-05830-LWS
    • IAB-05830-U
    • IAB-05840-LWS
    • IAB-05840-U
    • IAB-05850-LWS
    • IAB-06830-U
    • IAB-06840-U
    • IAB-06850-U
  • Devices Recalled in the U.S.: 16,959
  • Dates Distributed: May 7, 2022 to April 8, 2024
  • Date Initiated by Firm: April 29, 2024

Device Use

The Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kit are used with a balloon pump and together are used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.

Reason for Recall

Teleflex, and their subsidiary Arrow International, are recalling the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits after finding that a manufacturing error may cause the catheter’s balloon to become overtwisted.  The issue can sometimes be identified visually, but a device may still be impacted even if the issue cannot be detected visually and all mitigations outlined in this recall should be followed. This issue may: prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use.

Use of this device may cause serious injury, including blood loss, tearing in the artery (perforation), unstable blood pressure (hemodynamic instability), prevention of blood flow to the heart (myocardial ischemia), or death.

Teleflex/Arrow International reports 322 complaints. A total of 31 injuries and 3 deaths have been reported potentially related to this issue.

Who May Be Affected

  • People who receive circulatory support using the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit or Arrow UltraFlex Intra-Aortic Balloon Catheter Kits.
  • Health care professionals who provide care that includes using the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit or Arrow UltraFlex Intra-Aortic Balloon Catheter Kits.

What to Do

On April 29, 2024, Teleflex/Arrow International sent an Urgent Medical Device Notification letter to customers that included the following recommended actions:
For health care professionals:

  • Ensure that a back-up intra-aortic balloon catheter is available before using this device, in case a replacement is needed.
  • Inspect all intra-aortic balloon catheters in the scope of this recall for signs of an over-twisted balloon wrap or bent balloon shaft before use.
    • Over-twisting manifests as a progressive pitch or tightness within the helical wrap at either the distal or proximal end of the balloon.
    • Do not insert catheters suspected of manifesting an over-twisted wrap.
    • Important: Not all affected catheters will show a visibly over-twisted balloon wrap.
  • Use fluoroscopic guidance to insert all intra-aortic balloon catheters in the scope of this recall.
    • Once inserted and connected, fluoroscopy must be used to assess the completeness of balloon inflation. Fluoroscopic assessment must span the full length of the balloon (panning as necessary) and should include several cycles of inflation/deflation.
    • Intermittent fluoroscopy should remain available for up to 3 minutes after one-to-one cyclic counterpulsation begins, or until full balloon inflation is confirmed.
  • Be vigilant in responding to pump alarms consistent with the Instructions For Use and Users Guide.
    • If an Arrow AC3 or Autocat-2 pump is being used, a high-pressure alarm or high baseline alarm may sound and display on the pump console. These red-condition alarms require immediate attention per the Instructions For Use and Users Guide. The alarms provide users with a trouble shooting algorithm that includes incomplete IAB inflation.
    • If a Getinge CardioSave pump is being used, an IAB catheter restriction alarm may sound.
    • Any pump alarm indicating helium leakage (helium loss or gas loss) may signal the IAB catheter is not performing as expected.
  • Users should be vigilant in responding to bedside indicators that an intra-aortic balloon catheter is not performing as expected, including:
    • Blood in the helium pathway
    • Lower than expected diastolic pressure augmentation

If this issue is identified or suspected, immediately:

  • Remove the catheter and replace it using steps outlined in the Instructions for Use.
    • A replacement balloon catheter may be inserted contralaterally or ipsilaterally as determined by the responsible physician after considering the patient’s individual femoral access options and relevant clinical features.
  • Promptly report every suspected incidence of this condition to Teleflex using the contact information as soon as is practical. Your local sales representative can also assist with completing a report if needed.

For Medical Facilities

  • Immediately:
    • Check inventory for product within the scope of this recall.
  • Mark the applicable checkbox (affected product or no affected product) on the acknowledgement form included with the letter. Email the form to [email protected].

For Distributors

  • Immediately:
    • Provide a copy of the Urgent Medical Device Notification letter to all customers who have received impacted product. Each customer must complete the acknowledgement form and return it to the distributor.
    • Check inventory for product within the scope of this recall and place a copy of the Urgent Medical Device Notification with all affected product and ensure that the notification is included with future distributions of affected product.
  • Confirm to Teleflex that field activities outlined have been completed.
  • After completing actions, forward the completed acknowledgement form to [email protected].
  • If product was distributed outside of the country, notify Teleflex Customer Service.

Contact Information

Customers with questions should contact Teleflex/Arrow International Customer Service:
Phone: 1-866-396-2111
FAX: 1-855-419-8507
Email: [email protected]

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 


Related Content

News | FDA

July 2, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott has issued a correction for its ...

Home July 02, 2024
Home
News | FDA

June 18, 2024 — Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary ...

Home June 18, 2024
Home
News | FDA

June 17, 2024 — Elutia Inc., a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting ...

Home June 17, 2024
Home
News | FDA

June 13, 2024 — Xeltis, a leading developer of transformative implants that enable the natural creation of living and ...

Home June 13, 2024
Home
News | FDA

June 3, 2024 — Heuron, a specialized medical AI startup focused on brain and neurological disorders based in South Korea ...

Home June 03, 2024
Home
News | FDA

May 17, 2024 — Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has ...

Home May 17, 2024
Home
News | FDA

May 15, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling the HeartMate 3 LVAS by ...

Home May 15, 2024
Home
News | FDA

May 8, 2024 — The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our ...

Home May 08, 2024
Home
News | FDA

May 8, 2024 — 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally ...

Home May 08, 2024
Home
News | FDA

May 7, 2024 — RapidAI, the global leader in developing clinically deep Artificial Intelligence (AI) and technology ...

Home May 07, 2024
Home
Subscribe Now