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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74225

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

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Event summary

Timeline bucket
May 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Datascope Corporation

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

MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA

Z-1935-2016
Recall number
Z-1935-2016
Initiated
May 13, 2016
Classification
Class II
Status
Terminated
Recalling firm
Datascope Corporation
Quantity
31,030 units (US); 15,604 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

Code information

(PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)

Distribution pattern

Worldwide Distribution.

Field note

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