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.
- ZOOM 71 Reperfusion Catheter
- Product Codes and Lot Numbers: See Recall Database Entry
- Devices Recalled in the United States: 3,098
- Distribution Date: September 23, 2020 to August 9, 2021
- Date Initiated by Firm: August 18, 2021
The ZOOM 71 Reperfusion Catheter is used with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump) to remove blood clots in the brain of a patient within eight hours of an acute ischemic stroke caused by blocked or narrowed arteries.
Reason for Recall
Imperative Care Inc. is recalling specific lots of this product due to increased risk of the Zoom 71 Reperfusion Catheter breaking at a certain point (distal tip) during use, such as when the catheter is retracted forcefully. If the device breaks during use, this could lead to fractured pieces left inside the patient’s bloodstream resulting in serious adverse events such as blockage of blood vessels, stroke, and death.
There have been nine reports of serious injuries. There have been no deaths reported.
Who May Be Affected
- Health care providers using the affected ZOOM 71 Reperfusion Catheter
- Patients who have procedures with the affected ZOOM 71 Reperfusion Catheter
What to Do
On August 18, 2021, Imperative Care Inc. sent an “Urgent: Voluntary Medical Device Recall" letter to customers. The letter requested medical staff to:
- Share the recall notification with all users of the product within the facility to ensure they are also aware of the recall.
- Immediately review the inventory for the specific lot numbers listed in the letter.
- Remove and quarantine all unused affected products in the inventory.
- Return the affected products to Imperative Care.
- Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary.
- If a replacement product is needed, your local Imperative Care Sales Representative will be able to assist with identifying a suitable replacement product.
- Complete the Customer Confirmation Certificate attached to the “Urgent: Voluntary Medical Device Recall” letter and contact your local Imperative Care Sales Representative.
Customers who have questions about the notification should contact their local Imperative Care Sales Representative or Imperative Care Customer Service by phone at 1-408-502-7548 from Monday to Friday 7:00 a.m. to 5:00 p.m. PST or by emailing email@example.com.
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.