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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- component-separation
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:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- IL
- IN
- KS
- KY
- MA
- MD
- ME
- MI
- MN
- MO
- MT
- NC
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- TN
- TX
- UT
- VA
- VT
- WA
- WI
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