Agency classClass IOur severity:Severe FDA (Devices)·Z-1095-2022·Announced 2022-05-25

Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk

Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall indicating potential for serious patient harm. The classification as Class I requires a minimum severity score of 4. No deaths or reported illnesses are mentioned in the source text.

Plain-English summary

Abbott Vascular is recalling 14,544 Dragonfly OpStar Imaging Catheters (models 1014651 and 1014652) distributed throughout the United States and internationally. The recall addresses a potential risk that the proximal marker may separate from the imaging catheter during use.

The affected devices are identified by specific lot numbers for each model. Healthcare facilities that received these catheters should verify their stock against the identified lot numbers and contact Abbott Vascular for guidance on managing the recalled inventory.

The recalled product

Product: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Manufacturer: Abbott Vascular
Category: Medical Device — Imaging Catheter
Hazard: component-separation
Affected units: 14,544

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)

8211506
8127931
8211507
8127932
8220671
8127934
8220672
8131366
8220673
8131367
8220675
8131369
8257085
8131370
8257087
8147186
8274128 8147188
8294077 Model 1014652 - GTIN: (01) 05415067031112 Lot #:8111644
8192796
8131360

Distribution

Distributed in 44 states:

Same manufacturer · Abbott Vascular

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Same hazard · component separation