Z-1111-05

Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F

Name: Z-1111-05 Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
Creator: Medtronic Neurosurgery
Published: 2005-07-05
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2005-07-05 / Terminated

FDA source

Medtronic Neurosurgery began a recall of Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F on 2005-07-05. The reason FDA records is "Cracked hubs/handles and/or improper peeling of the sheath during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1111-05
Status: Terminated
Initiated: 2005-07-05
Posted: 2005-08-10
Terminated: 2008-06-26
Recalling firm: Medtronic Neurosurgery
Product: Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
Product code: GWG Endoscope, Neurological
Reason for recall: Cracked hubs/handles and/or improper peeling of the sheath during use.
FDA root cause: Other
Action: Firm sent recall letters by Fedex on July 5, 2005 to all customers.
Quantity in commerce: 79
Distribution: Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
Product codes and lots: Lots: A55754, A59282, A62361, A64132

Product code GWG

K990333Class IIMedtronic Ps Medical Introducer Sheath 12F,14f,15f, Models 3805-012, 3805-014, 3805-015Medtronic PS Medical / cleared 1999-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)