Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethyle

FDA device recall Z-0197-2010 · posted 2009-11-13 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.

Action taken

An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.

Root cause

Other

Status

Terminated

Product code

DQY

Quantity affected

9800 total (2373 US and 7427 OUS)

Distribution

Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI,

Date initiated

2009-09-29

Date posted

2009-11-13

Date terminated

2011-12-17

Location

Maple Grove, MN

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