Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Product Description and Material/UPN/Catalog Number Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) M0064003011 (outer box); Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) M0064003021 (outer box) and Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) M0064003031 (outer box) The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

FDA Recall Z-0337-2010 · Posted 2010-01-21

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKOD
Date Initiated2009-10-22
Date Terminated2011-12-12
Product Quantity74 boxes (5/box) US; 18 boxes (5/box) OUS

Reason for Recall

The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.

Firm Action

Two Boston Scientific "Urgent Voluntary Medical Device Recall" letters were sent to consignees on October 29, 2009. The letters described the problem and the affected product. Consignees were instructed to cease use and distribution of the product and to complete and return the Account Reply Verification Tracking Form. The first letter with the heading, "Boston Scientific IMAGER II Angiographic Catheter (Peripheral Intervention)", was addressed to the Risk Manager/Field Action Contact. The second letter with the heading, "Imager II Urology Torque Catheters" was addressed to the Risk/Materials Manager. Direct questions about the recall to your local Sales Representative or Boston Scientific Corporation by calling at 1-763-494-1700.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011965IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1Boston Scientific Corp · 2001-07-13

Official Source

View FDA Recall →

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

↑