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AMBLER SURGICAL CORP. · Model Heaney-Ballentine hysterectomy forceps · UDI-DI 00190660056094

HGC Prescription
2
510(k) clearances
16
Adverse events
11
Recalls
70
Facilities

Description

Heaney-Ballentine hysterectomy forceps, 10 1/2'', curved, longitudinal serrated, single-toothed jaws, ring handle

Recalls

DateFirmReason
2025-01-31Aesculap IncThe forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
2010-10-19Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.