R4 Vascular Inc: DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

Recall number

Z-2412-2011

Recalling firm

R4 Vascular Inc

Product

DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

Status

Terminated

Initiated

2011-05-03

Posted

2011-06-06

Terminated

2012-07-27

Reason

r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lot

Root cause

Nonconforming Material/Component

Action

R4 Vascular Inc sent an Urgent Medical Device Recall letter dated May 3, 2011, to all affected customers. The letter described the problem and the product being recalled. Consignees were instructed to stop distributing the product and to quarantine the recalled lots and if they had already distributed the affected product to seek its return from their customers. A template letter to physicians and healthcare facilities was enclosed for Distributors/Retailers to send or hand deliver to their customers. For questions regarding this recall call 1-704-905-2105.

Quantity

2489 kits

Distribution

Nationwide Distribution including CA, CO, CT, FL, GA, IL, LA, MD, MA, MN, MS, MO, NJ, NC, OH, PA, SC, TX, and WA.

Lot, serial or model codes

42 Lots Total in total: R401D035P R401D049P R401D053P R401D055P R401D056P R401D057P R401D060P R401D092P R401D097P R401D098P R401D099P R401D102P R401D123P R401D124P R401D125P R401D126P R401D169P R401D217P R401D218P R401D250P R401D251P  R402D050P R402D056P R402D057P R402D097P R402D102P R402D130P R402D138P R402D162P R402D168P R402D217P R402D250P   R403D057P R403D097P R403D123P R403D140P R403D159P R403D196P R403D217P  R404D057P R404D196P  D405D057P

510(k) numbers

["K091506","K100169"]

PMA numbers

not on file

Product code

MSD

Firm FEI

3006242715

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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