Skip to content
Recall Observatory FDA recall evidence

Device product

Hobbs Medical Polypectomy Snare, Catalog No. 7202

Z-1388-2022

June 03, 2022

Class II

Product summary

Firm
Hobbs Medical, Inc.
Event
Event 90456
Status
Ongoing
Classification
Class II
Quantity
45 (US)
Official record key
device-enforcement:Z-1388-2022

Official wording

Reason: During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.

Code information: UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167

Distribution pattern: Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.