Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set (5/bx) Material/UPN/Catalog Number: M

FDA device recall Z-2208-2009 · posted 2009-09-22 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.

Action taken

Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.

Root cause

Process design

Status

Terminated

Product code

MNB

Quantity affected

1,555 eaches

Distribution

Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.

Date initiated

2009-07-31

Date posted

2009-09-22

Date terminated

2011-05-03

Location

Marlborough, MA