Boston Scientific Recalls 1068 Peripheral Imaging Catheters Due to Guidewire Issues
Boston Scientific is recalling 1,068 units of the Atlantis PV 8.5F Peripheral Imaging Catheter because physicians reported an inability to pass a guidewire through the device.
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, and the source text describes a functional defect (inability to pass a guidewire) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Boston Scientific Corporation is recalling 1,068 single units of the Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter. The product is a sterile, irradiated ultrasound imaging catheter intended to operate with an intravascular ultrasound (IVUS) instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035-inch guidewire.
The recall was initiated due to reports of physicians experiencing an inability to pass a 0.035-inch guidewire through the guidewire lumen and exit port at the proximal Y-manifold of the imaging catheter. The affected units were distributed nationwide in the United States and in Mexico. The specific lot numbers and expiration dates for the recalled units are listed in the agency's structured product information.
This is a Class II recall, which means the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers and healthcare providers should stop using the affected devices and contact Boston Scientific Corporation for further instructions on return or replacement.
The recalled product
- Product
- Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1,068
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 (20)
- Product number: H749364560
- Catalog number: 36456
- Lot numbers: 16159358
- 16183964
- 16230195
- 16230673
- 16247263
- 16257809
- 16268498
- 16289177
- 16311356
- 16330543
- 16342824
- 16419885
- 16420624
- 16420903
- 16447744
- 16458536
- 16486133
- 16494530
Distribution
Distributed nationwide across the United States.
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 · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- HighBoston Scientific Recalls Opticross 35 Peripheral Imaging Catheters
FDA (Devices) · 2020-10-28
- ModerateBoston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
FDA (Devices) · 2014-06-25
- ModerateBoston Scientific Recalls Small Peripheral Cutting Balloon Catheters
FDA (Devices) · 2013-09-11
- ModerateBoston Scientific Recalls Guidezilla II Catheters Due to Missing Coating
FDA (Devices) · 2019-12-04
- SevereBoston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- HighBoston Scientific Recalls Polaris Ultra Ureteral Stent Sets
FDA (Devices) · 2020-04-29