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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70644

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

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Event summary

Timeline bucket
February 23, 2015
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medtronic Inc. Cardiac Rhythm Disease Management

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

Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

Z-1276-2015
Recall number
Z-1276-2015
Initiated
February 23, 2015
Classification
Class I
Status
Terminated
Quantity
151 (4 US, 147 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

Code information

Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.

Distribution pattern

Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.