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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82746

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 01, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Vascular

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Z-1687-2019
Recall number
Z-1687-2019
Initiated
May 01, 2019
Classification
Class II
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.

Code information

All Serial Numbers.

Distribution pattern

U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MACAU, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED KINGDOM