# FDA recall Z-1095-2022

> **Abbott Vascular** · Class I · device recall initiated 2022-03-30.

## Product

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652,  0.068 in, 0.014 in, 135 cm, STERILE EO

## Reason for recall

There is a potential that the proximal marker may separate from the imaging catheter

## Distribution

US:AL	AR	AZ	CA	CO	CT	DC	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, PR    OUS: AE, AT, AW, BE, CA, CH, DE, DK, IT, JP, LU, NL, NO, NZ, PL, EE, ES, FI, FR, GB, HK, HU, IE, PT, RO, SE, SG, SI, TH

## Key facts

- **Recall number:** Z-1095-2022
- **Recalling firm:** Abbott Vascular
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-30
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temecula, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2022

## Citation

> AI Analytics. FDA recall Z-1095-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1095-2022. Source: US FDA. Licensed CC0.

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