Boston Scientific Imager II Angiographic Catheter Recall for Missing Seal
Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (missing seal) that is explicitly described as obvious to the user, and no injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 39 boxes (195 units) of Imager II Angiographic Catheters, lot 00112758, with a use-by date of May 11, 2018. The affected product is a medical device used to deliver contrast media to selected sites in the vascular system.
The recall was initiated after a field report indicated that some units within this lot were missing the bottom pouch seal. The source text notes that the compromised seal is completely missing and is obvious to the user.
The affected units were distributed in California, Florida, Kentucky, Missouri, New Mexico, Oklahoma, Oregon, Pennsylvania, and Texas. Users should check their inventory for this specific lot and use-by date. If the bottom pouch seal is missing, the device should not be used.
The recalled product
- Product
- Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 00112758
- Use by 2018-05-11
Distribution
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateBoston Scientific Recalls Imager II Angiographic Catheters Due to Packaging Mislabeling
FDA (Devices) · 2017-04-19
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- CriticalBoston Scientific Recalls Imager II 5F Angiographic Catheters Due to Tip Detachment Risk
FDA (Devices) · 2020-04-01
- LowBoston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals
FDA (Devices) · 2021-03-10
- SevereBoston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks
FDA (Devices) · 2016-04-27
- LowBoston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error
FDA (Devices) · 2013-07-24