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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65395

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

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Event summary

Timeline bucket
May 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bard Peripheral Vascular 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

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

BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.

Z-1533-2013
Recall number
Z-1533-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
415

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

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Inspect official wording and provenance

Reason for recall

Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.

Code information

Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090

Distribution pattern

US Nationwide Distribution