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Open, Classified

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5

FDA Recall Z-3214-2026 · Posted 2026-09-23

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2026-08-24
Product Quantity262,686

Reason for Recall

Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Firm Action

Firm began notifying customers on August 24, 2026. Customers were instructed to immediately stop further use or distribution and segregate affected product. Customers should continue to follow the standard of care when monitoring patients treated with the product. Customers were advised to utilize both inner and outer packaging UPN codes when searching for affected product. Customers were provided with instructions to return product.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Rep N Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad, Tobago, Tunisia, T¿rkiye, UAE, Ukraine, United Kingdom, USA, W. Bank Gaza Strip, Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121694IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific Corp · 2012-09-14

Official Source

View FDA Recall →

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

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