The United States Food and Drug Administration (FDA) has classified Imperative Care’s ZOOM 71 Reperfusion Catheter recall as a Class I recall. Class I recalls are the FDA’s most severe type of product recall, and these recalls are reserved for products that may cause severe injuries or death.
Imperative Care Incorporated is recalling certain lots of their catheters due to a serious and increased risk of the Zoom 71 Reperfusion Catheter breaking at the distal tip when the catheter is retracted with force. Should the device break during a surgical procedure, the fractured pieces could be left inside the patient’s bloodstream, causing severe adverse medical events, including blood vessel blockage, stroke, and death. Imperative Care is recalling 3,098 ZOOM 71 Reperfusion Catheters in the United States. The catheters were distributed from September 23, 2020, until August 9, 2021.
The recall announcement states that there have been nine incident reports. No fatalities have been reported at this time.
Imperative Care’s ZOOM 71 Reperfusion Catheters are used along with the ZOOM Aspiration Pump (or equivalent vacuum pump) and ZOOM Aspiration Tubing. The procedure removes blood clots from the patient’s brain and is used within eight hours of the patient suffering an acute ischemic stroke produced by narrowed or blocked arteries.
A few months ago, Imperative Care Incorporated issued its customers an “Urgent, Voluntary Medical Device Recall” letter. The recall letter urged medical professionals to:
- Share the ZOOM 71 Reperfusion Catheter’s recall notification with users of the device within the medical facility to make certain everyone is aware of this recall.
- Immediately check their inventory for the recalled lot numbers.
- Remove and isolate any unused recalled catheters from their inventory.
- Return the recalled catheters to Imperative Care.
According to the recall announcement, local Imperative Care Sales Representatives are available to help clinics with facilitating the return of the recalled ZOOM 71 Reperfusion Catheters. Should a clinic need a replacement, a local Imperative Care Sales Representative will be able to help identify a suitable replacement catheter kit. Customers with questions concerning the recall should contact Imperative Care Customer Service or the local Imperative Care Sales Representative. Additional information can be found on the company’s website located at imperativecare.com.
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