The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr
- Product Codes and Lot Numbers: See Recall Database Entry
- Devices Recalled in the United States: 3,241
- Distribution Date: November 1, 2019 to July 31, 2021
- Date Initiated by Firm: August 11, 2021
The Arrow-Trerotola Over-The-Wire (PTD) Kit Percutaneous Thrombolytic Device: 7FR includes a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow-Trerotola Percutaneous Thrombolyic Device (PTD) Catheter is used with the Arrow Rotator Drive Unit, to remove clots in adult patients who have arterio-venous (AV) fistulas and synthetic dialysis grafts.
Reason for Recall
Arrow International Inc, a subsidiary of Teleflex, is recalling the Arrow-Trerotola Over-The-Wire 7FR PTD Kits due to the risk of the orange inner lumen of the catheter's tip component separating from the basket.
Figure 1: Close up of the orange inner lumen and self-expanding basket
If the orange inner lumen separates from the basket, it may fracture and detach and block the blood vessel(s). If the orange inner lumen detaches from the basket, health consequences depend upon where the fractured tip component embolizes. If the embolization is local to the treatment target site, retrieval may be attempted, requiring an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or possibly even to the heart or pulmonary arteries. This may lead to serious adverse events such as vessel damage, need for additional medical procedures, or possibly death.
There have been seven complaints and no injuries or deaths reported for this device.
Who May Be Affected
- Health care providers using the affected Arrow-Trerotola Over-The-Wire 7FR Percutaneous Thrombolytic Device (PTD) Kits
- Patients receiving treatment using the affected Arrow-Trerotola Over-The-Wire 7FR Percutaneous Thrombolytic Device (PTD) Kits
What to Do
On September 20th, 2021, Teleflex sent an "URGENT – FIELD SAFETY NOTICE" letter to customers requesting:
- Check your inventory for affected product listed in this "Urgent - Field Safety Notice"
- If you do have the affected product:
- Remove all affected product from inventory and place them in quarantine
- Complete the Acknowledgement Form (Appendix 1) of the "Urgent - Field Safety Notice" and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to firstname.lastname@example.org
- This will allow Teleflex to document the amount of product on hand for return
- A customer service representative will reach out with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical
- If you do not have any of the affected product:
- Mark the according checkbox on the Acknowledgement Form (Appendix 1) of the "Urgent - Field Safety Notice" letter and return the form to the fax number or e-mail address mentioned in the letter
- Provide the "Urgent - Field Safety Notice" to all customers who have received products within the scope of this recall
- Check your inventory for affected products listed in this Urgent- Field Safety Notice
- Cease use and distribution of the impacted product and quarantine immediately
- Return all product within scope to Teleflex
- Confirm with Teleflex the field activity has been completed as outlined above
- Upon completion, forward the completed Acknowledgement Form enclosed in the "Urgent - Field Safety Notice" to Customer Service
- If there is further distributed product outside of your country, let Teleflex know by emailing to the following e-mail address: Recalls@teleflex.com
Customers who have questions about this recall should contact Teleflex customer service by phone at 1-866-396-2111, by fax at 1-855-419-8507, or by email at Recalls@teleflex.com.
- Medical Device Recall Database Entry Part 1
- Medical Device Recall Database Entry Part 2
- Medical Device Recall Database Entry Part 3
- Medical Device Recall Database Entry Part 4
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.