TOPIC: 072 Aspiration System (Hippo) by Q’Apel Medical: Recall and Discontinuation - Due to Distal Tip Design Outside Scope of 510k Clearance
AUDIENCE: Patient, Health Care Professional, Risk Manager
ISSUE: The FDA classified Q’Apel Medical Inc's recall of 1,617 units of its 072 Aspiration System as Class I.
Q’Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment, retrieved without patient injury; a vessel rupture; and a vasospasm. Based on the company’s investigation of these events, factors other than the device’s distal tip likely contributed to the reported adverse events.
The product was distributed in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: On February 26, 2025, the company initiated a discontinuation and recall of 1,617 units of its 072 Aspiration System product. The recall was initiated because the company received a Warning Letter from FDA that raised questions about whether the features and characteristics of the distal tip of the Hippo aspiration catheter were within the scope of its 510 (k) clearance. Rather than pursue a new regulatory pathway, the company chose to voluntarily remove all affected product lots and discontinue the 072 Aspiration System line as part of its strategic shift toward newer technologies.
The following product configurations have been removed and discontinued:
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072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing; Catalog Number: APT6072-132; Unique Device Identifier: 00857545008127; Lots: FG241008C-03, FG240916C-04, FG240905C-04
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072 Aspiration System (Hippo with Cheetah Delivery Tool); Catalog Number: AP6072-132; Unique Device Identifier: 00857545008097; Lots: FG241206A-03, FG240917A-01
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072 Aspiration Tubing; Catalog Number: APT-95; Unique Device Identifier: 00857545008103; Lot: FG241206A-04
RECOMMENDATIONS:
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The Hippo product configurations described above have been discontinued in all markets. The company has proactively notified all customers and distributors and will continue to monitor the situation closely.
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Consignees of the product should immediately return any available product inventory to the company. If consignees have distributed the product to others, contact Q’Apel so that the company can notify them of this action and retrieve any remaining product.
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For questions or assistance with product return, please contact: Q’Apel Medical Inc. – Customer Service Phone: 510-738-6255 or Email: orders@qapelmedical.com.
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