Z-1851-2012Class II

Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The...

Name: Z-1851-2012 Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The...
Creator: Boston Scientific Corporation
Published: 2012-05-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-05-16 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of... on 2012-05-16. FDA classified it as Class II and gives the reason as "Difficulty in extending snare loop from the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1851-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-16
Posted: 2012-06-21
Terminated: 2013-02-28
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Product code: FDI Snare, Flexible
Reason for recall: Difficulty in extending snare loop from the catheter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.
Quantity in commerce: 1970 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Product codes and lots: Lot Numbers: 14951482, 14951484, 15068143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1850-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21
Z-1851-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21
Z-1852-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21

Product code FDI

K941750Class IIProposed Trademan Microvasive Polypectomy SnaresBoston Scientific Corp / cleared 1994-11-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)