ev3 Pacific Xtreme Balloon Dilation Catheter Recalled for Labeling Error
ev3 Inc. is recalling Pacific Xtreme balloon dilation catheters due to a labeling discrepancy regarding the Rated Burst Pressure value.
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 involves a labeling discrepancy. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
ev3 Inc. is recalling 4,286 units of the Pacific Xtreme (PTCA Balloon Dilation Catheter) due to a labeling discrepancy for the Rated Burst Pressure (RBP) value. The affected devices are distributed domestically across numerous U.S. states and internationally in Canada and Puerto Rico.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text identifies the specific issue as a labeling error concerning the RBP value but does not report any illnesses, injuries, or deaths associated with the use of these devices.
Healthcare providers and consumers should check their inventory for the specific model and lot numbers listed in the official recall notice. The expiration dates for the affected devices range from March 22, 2022, to April 21, 2023.
The recalled product
- Product
- Pacific Xtreme (PTCA Balloon Dilation Catheter)
- Manufacturer
- ev3 Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 4,286
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)
- Model: PCU060150090 Lot Numbers: 217978890
- 218622060. Model: PCU060150130 Lot Numbers: 217466573
- 217603335
- 217790972
- 217860448
- 217876552
- 217892598
- 217951979
- 218153799
- 218217163
- 218424513
- 218482262
- 218557813
- 218639138
- 218712737
- 218732096
- 218745770
- 218815063
- 218902560
- 218998027
Distribution
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