The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1512-2025·Announced 2025-04-16

Hippo 072 Aspiration System recalled for distal tip detachment risk

Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a medical device. Although no illnesses or injuries have been reported, Class I recalls are by definition subject to a minimum severity score of 4 per the rubric, as they involve a serious hazard to health or safety. The potential for vessel rupture represents significant risk of harm.

Plain-English summary

Qapel Medical Inc. is recalling the Hippo 072 Aspiration System (including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132), the Hippo 072 Aspiration System with Cheetah Delivery Tool (REF: AP6072-132), and the 072 Aspiration Tubing (REF: APT-95). The aspiration catheter distal tip features and characteristics may not be within the scope of FDA clearance.

The distal tip may detach during use, which could result in vessel rupture or vasospasm. A total of 1,617 units have been distributed across the United States (including California, Illinois, Nebraska, Tennessee, Texas, New Jersey, North Carolina, South Dakota, Florida, Michigan, Pennsylvania, Georgia, Alabama, Indiana, New York, Wisconsin, Arizona, Minnesota, Louisiana, Ohio, Oklahoma, South Carolina, Nevada, North Dakota, Idaho, Missouri, Connecticut, Washington, and Massachusetts) and internationally to Qatar, United Arab Emirates, and Kazakhstan.

Affected lot numbers and expiration dates are included in the recall notice. Hospitals and healthcare facilities that have received these products should stop use immediately and contact Qapel Medical Inc. for further guidance or return instructions.

The recalled product

Product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Manufacturer
Qapel Medical Inc.
Category
Medical Device — Aspiration Catheter System
Hazard
Affected units
1,617

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • REF/UDI-DI/Lot(Expiration): APT6072-132/00857545008127/FG241008C-03(04/07/2025)
  • FG240916C-04(03/17/2025)
  • FG240905C-04(03/06/2025). AP6072-132/00857545008097/FG241206A-03(06/08/2025)
  • FG240917A-01(03/17/2025). APT-95/00857545008103/FG241206A-04(06/08/25)

Distribution

Distributed in 29 states:

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