Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64527

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 27, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arrow International Inc

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

2 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 2

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

Z-1064-2013
Recall number
Z-1064-2013
Initiated
November 27, 2012
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
188 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Code information

Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921

Distribution pattern

Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

device · product 2 of 2

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

Z-1065-2013
Recall number
Z-1065-2013
Initiated
November 27, 2012
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
637 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Code information

Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059

Distribution pattern

Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.