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Terminated

Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F

FDA Recall Z-1110-05 · Posted 2005-08-10

Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeGWG
Date Initiated2005-07-05
Date Terminated2008-06-26
Product Quantity366

Reason for Recall

Cracked hubs/handles and/or improper peeling of the sheath during use.

Firm Action

Firm sent recall letters by Fedex on July 5, 2005 to all customers.

Root Cause

Other

Distribution Pattern

Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990333MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015Medtronic PS Medical · 1999-04-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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