Imperative Care Issues Voluntary Recall of Specific Lots of Zoom 71 Reperfusion Catheter

August 18, 2021—Imperative Care issued a notice to its customers, including health care professionals, risk managers, directors of purchasing, and recall coordinators advising that the company is voluntarily recalling specific lots of the Zoom 71 reperfusion catheters.

The recall was initiated because the company has identified a potential risk where certain Zoom 71 devices belonging to these specific lots can experience a distal end fracture and become detached, including but not limited to when the catheter is retracted against significant resistance, or the catheter is retracted through a kinked guide catheter or other constraints.

The company stated that if the distal end becomes fractured, it can remain in the patient, which could lead to prolongation of the procedure, vascular injury, occlusion, stroke, or possibly death resulting from any of the prior sequelae. The device failure may also require additional interventions, including but not limited to, the retrieval of fractured pieces, which in turn carries inherent risks.

Through August 17, 2021, Imperative Care is aware of eight reports associated with this device failure. Eight serious injuries and zero deaths have been reported due to the failure mode associated with this recall. In four of these incidents, the fractured distal end was removed from the patient via an additional procedure; in the other four incidents, the fractured distal end was left in place.

Imperative Care is requesting the return of affected products and has taken the steps to prevent further shipment of the affected product. For an affected product that has been used, no action is necessary, and patients should continue to be managed in accordance with standard patient management protocols, noted the company.

Further details about the recall and actions to be taken are available in the company’s letter to customers from Imperative Care’s Donielle Baudin, who is Senior Director, Quality Assurance. The letter is available online.